The drug regulator’s recent suspension of Sun Pharmaceutical Industries’ clinical research activities at its Mumbai-based bio-analytical laboratory has raised concerns among other companies doing similar research and development work.

The pharmaceutical industry is particularly worried that following the recent directives from the Supreme Court, the regulator may turn more stringent, impacting ongoing projects and future clearances.

While the regulator has suspended Sun Pharma’s Mumbai laboratory citing absence of approval for the site, the firm maintains it has complied with all existing regulatory requirements.

“The company believes it has complied with all existing regulatory requirements. It is rather unfortunate that ambiguity in guidelines has caused this situation. The company is working with the authorities to resolve this issue at the earliest,” said a Sun Pharma spokesperson.

According to an industry official, who does not wish to be named, the drug maker was conducting an additional analytical test at its Mumbai laboratories and had informed the regulator about it through a letter.

“Such practices were permissible till recently. It is merely an additional analytical test and not a human trial for which you require proper approval etc. In the past, companies have been informing the regulator about such studies through letters and an objection has never been raised,” he said.

While the Drugs Controller General of India (DCGI) G N Singh, who is currently on an official tour to China, could not be reached, other senior drug inspectors at the drug regulator’s office refused to comment on the issue.

An official from another research-oriented pharmaceutical company said the latest action by the regulator could be a fallout of the stricter directives by the Supreme Court, which has asked the government to keep a stringent check on clinical trials conducted in India. However, the official said the government and the regulator should implement the apex court’s directives in a manner that it should not impact business.

“The regulator should act in a manner that should not hamper usual business. Our fear is the latest directives by the apex court will be misunderstood and used to create unnecessary enforcements,” said the official.

According to companies and clinical research organisations, the industry is not shying away from stricter regulations but they should be balanced and must take care of interests of all stakeholders. The industry fears that in order to prove itself, the regulator may crack more companies without enough reasons.

“Given the recent developments, the fear is that regulations should not be a knee-jerk reaction to activism,” says Suneela Thatte, president of Indian Society of Clinical Research (ISCR). According to Thatte, the SC directives are not in the direction of creating more norms, rather asking the government to adhere to and implement the existing regulations.

According to officials, the government is observing caution while approving clinical trials and new products. Over 150 applications of clinical trials seeking approvals are reportedly pending with the DCGI’s office. So far this year, merely five trials have received approval.

According to market research firm Frost & Sullivan, the Indian clinical trial industry was worth $450 million in 2010–11. Currently, it is growing at 12 per cent a year and is predicted to pass the $1-billion mark in 2016. However, recent developments have derailed progress.

Regulator's moves worry pharma sector

Pharmaceutical industry is particularly worried that following the recent directives from the Supreme Court

Pharmaceutical industry is particularly worried that following the recent directives from the Supreme Court
The drug regulator’s recent suspension of Sun Pharmaceutical Industries’ clinical research activities at its Mumbai-based bio-analytical laboratory has raised concerns among other companies doing similar research and development work.

The pharmaceutical industry is particularly worried that following the recent directives from the Supreme Court, the regulator may turn more stringent, impacting ongoing projects and future clearances.

While the regulator has suspended Sun Pharma’s Mumbai laboratory citing absence of approval for the site, the firm maintains it has complied with all existing regulatory requirements.

“The company believes it has complied with all existing regulatory requirements. It is rather unfortunate that ambiguity in guidelines has caused this situation. The company is working with the authorities to resolve this issue at the earliest,” said a Sun Pharma spokesperson.

According to an industry official, who does not wish to be named, the drug maker was conducting an additional analytical test at its Mumbai laboratories and had informed the regulator about it through a letter.

“Such practices were permissible till recently. It is merely an additional analytical test and not a human trial for which you require proper approval etc. In the past, companies have been informing the regulator about such studies through letters and an objection has never been raised,” he said.

While the Drugs Controller General of India (DCGI) G N Singh, who is currently on an official tour to China, could not be reached, other senior drug inspectors at the drug regulator’s office refused to comment on the issue.

An official from another research-oriented pharmaceutical company said the latest action by the regulator could be a fallout of the stricter directives by the Supreme Court, which has asked the government to keep a stringent check on clinical trials conducted in India. However, the official said the government and the regulator should implement the apex court’s directives in a manner that it should not impact business.

“The regulator should act in a manner that should not hamper usual business. Our fear is the latest directives by the apex court will be misunderstood and used to create unnecessary enforcements,” said the official.

According to companies and clinical research organisations, the industry is not shying away from stricter regulations but they should be balanced and must take care of interests of all stakeholders. The industry fears that in order to prove itself, the regulator may crack more companies without enough reasons.

“Given the recent developments, the fear is that regulations should not be a knee-jerk reaction to activism,” says Suneela Thatte, president of Indian Society of Clinical Research (ISCR). According to Thatte, the SC directives are not in the direction of creating more norms, rather asking the government to adhere to and implement the existing regulations.

According to officials, the government is observing caution while approving clinical trials and new products. Over 150 applications of clinical trials seeking approvals are reportedly pending with the DCGI’s office. So far this year, merely five trials have received approval.

According to market research firm Frost & Sullivan, the Indian clinical trial industry was worth $450 million in 2010–11. Currently, it is growing at 12 per cent a year and is predicted to pass the $1-billion mark in 2016. However, recent developments have derailed progress.